Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454948
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2007-03-29
Brief Title:
Nutrition Intervention and Play Group Exercise for Low-income Latinas
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Home Based Nutrition Intervention Nad Play Group Exercise for Low-income Latinas
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHICOS
Brief Summary:
Obesity among Mexican-American women has the potential to become a public health crisis Hispanics are one of the fastest growing minority populations in the United States and the prevalence of obesity in Mexican American woman is increasing at an alarming rate Poor dietary practices especially food habits that are acquired as families acculturate to the American food supply and lack of exercise are thought to be associated with womens excess weight gain Accordingly interventions are needed to improve the dietary intake and physical activity levels of Mexican-American families
We propose to conduct a randomized clinical trial in which women are randomly assigned to receive either family-based behavioral counseling FBC sessions and play group physical activity sessions or group based nutrition and exercise classes and health related activity worksheets to complete with their child The FBC sessions conducted by community health advisors will use photographs of the familys food practices taken by mothers as visual aids in the counseling sessions The control intervention will consist of group sessions using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid recommendations using traditional Mexican-American foods The primary outcome of the trial is mothers BMI The secondary outcomes are dietary intake moderate to vigorous physical activity and household food supplies We hypothesize that within a one year time frame women who are exposed to the FBC will have lower BMIs compared to women who receive the active placebo control intervention The mechanisms through which we intend to change weight status are altering the type of foods purchased and cooking practices and promoting mothers to engage in physical activities with their children during their play Measurements of secondary outcomes include three 24 hour dietary recalls a household food inventory and activity monitoring using MTI actigraph monitors In addition mothers reports of household food security level and food purchase motives will be collected as covariates Measurements will be collected within one month of completing the interventions and at six months and one year follow-up
We propose to conduct a randomized clinical trial in which women are randomly assigned to receive either family-based behavioral counseling FBC sessions and play group physical activity sessions or group based nutrition and exercise classes and health related activity worksheets to complete with their child The FBC sessions conducted by community health advisors will use photographs of the familys food practices taken by mothers as visual aids in the counseling sessions The control intervention will consist of group sessions using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid recommendations using traditional Mexican-American foods The primary outcome of the trial is mothers BMI The secondary outcomes are dietary intake moderate to vigorous physical activity and household food supplies We hypothesize that within a one year time frame women who are exposed to the FBC will have lower BMIs compared to women who receive the active placebo control intervention The mechanisms through which we intend to change weight status are altering the type of foods purchased and cooking practices and promoting mothers to engage in physical activities with their children during their play Measurements of secondary outcomes include three 24 hour dietary recalls a household food inventory and activity monitoring using MTI actigraph monitors In addition mothers reports of household food security level and food purchase motives will be collected as covariates Measurements will be collected within one month of completing the interventions and at six months and one year follow-up
Detailed Description:
We propose to evaluate a family-based intervention designed to prevent obesity by increasing fruit and vegetable FV intake decreasing fat intake and increasing physical activity The target group for the intervention is low-income Mexican-American mothers of preschool aged children The intervention uses family-based behavioral counseling FBC sessions with a community health advisor CHA to promote changing the types of foods that mothers prepare and consume and increasing the time that mothers spend being active with their children In previous research we have used this approach to improve Mexican-American school aged childrens nutritional status The mothers of these children were extremely motivated to improve their childrens diets and in doing so improved their own health behaviors and reduced their BMIs Accordingly in the proposed research we will conduct a randomized controlled trial with a sample of 250 Mexican-American mothers-child dyads to evaluate a family based intervention designed to prevent obesity in low income Mexican-American women As families enroll in the study they will be randomly assigned to either the FBC sessions or an active placebo control condition Data will be collected immediately prior to participation in the intervention within one-month of completing the intervention and at six months and one year follow-up Mothers body mass index BMI will serve as the primary outcome variable Multiple 24-hour dietary recalls a modified household food inventory and physical activity monitoring will be used as secondary indices of program efficacy The following hypotheses will be examined in this experiment
Primary Hypothesis Women who receive the FBC sessions will have significantly lower BMI one year after randomization into the intervention compared to women whose families receive an active placebo control
Secondary Hypotheses
Women who receive the FBC sessions will have significantly lower fat intakes and higher fruit and vegetable intakes as measured by 24 hour recalls one year after randomization into the intervention compared to women whose families receive an active placebo control
Women who receive the FBC sessions will have significantly fewer high fat foods and significantly more fruits and vegetables in their homes as measured by targeted household food inventories one year after randomization into the intervention compared to women whose families receive an active placebo control
Women who receive the FBC sessions will be significantly more active one year after randomization into the intervention as measured by activity monitoring compared to women whose families receive an active placebo control
Primary Hypothesis Women who receive the FBC sessions will have significantly lower BMI one year after randomization into the intervention compared to women whose families receive an active placebo control
Secondary Hypotheses
Women who receive the FBC sessions will have significantly lower fat intakes and higher fruit and vegetable intakes as measured by 24 hour recalls one year after randomization into the intervention compared to women whose families receive an active placebo control
Women who receive the FBC sessions will have significantly fewer high fat foods and significantly more fruits and vegetables in their homes as measured by targeted household food inventories one year after randomization into the intervention compared to women whose families receive an active placebo control
Women who receive the FBC sessions will be significantly more active one year after randomization into the intervention as measured by activity monitoring compared to women whose families receive an active placebo control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None